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30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

9 oktober 2014 bijgewerkt door: Boehringer Ingelheim

A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

936

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Bad Lauterberg / Harz, Duitsland
        • 1264.3.49001 Boehringer Ingelheim Investigational Site
      • Dietzenbach, Duitsland
        • 1264.3.49007 Boehringer Ingelheim Investigational Site
      • Dortmund, Duitsland
        • 1264.3.49002 Boehringer Ingelheim Investigational Site
      • Essen, Duitsland
        • 1264.3.49009 Boehringer Ingelheim Investigational Site
      • Hamburg, Duitsland
        • 1264.3.49003 Boehringer Ingelheim Investigational Site
      • Ingelheim, Duitsland
        • 1264.3.49012 Boehringer Ingelheim Investigational Site
      • Leipzig, Duitsland
        • 1264.3.49008 Boehringer Ingelheim Investigational Site
      • Mainz, Duitsland
        • 1264.3.49005 Boehringer Ingelheim Investigational Site
      • Offenbach, Duitsland
        • 1264.3.49010 Boehringer Ingelheim Investigational Site
      • Stuhr, Duitsland
        • 1264.3.49004 Boehringer Ingelheim Investigational Site
  • Estland
      • Harju, Estland
        • 1264.3.37207 Boehringer Ingelheim Investigational Site
      • Pärnu, Estland
        • 1264.3.37209 Boehringer Ingelheim Investigational Site
      • Tallin, Estland
        • 1264.3.37203 Boehringer Ingelheim Investigational Site
      • Tallin, Estland
        • 1264.3.37204 Boehringer Ingelheim Investigational Site
      • Tallin, Estland
        • 1264.3.37205 Boehringer Ingelheim Investigational Site
      • Tallinn, Estland
        • 1264.3.37201 Boehringer Ingelheim Investigational Site
      • Tallinn, Estland
        • 1264.3.37202 Boehringer Ingelheim Investigational Site
      • Tallinn, Estland
        • 1264.3.37208 Boehringer Ingelheim Investigational Site
      • Tartu, Estland
        • 1264.3.37206 Boehringer Ingelheim Investigational Site
      • Viljandi County, Estland
        • 1264.3.37210 Boehringer Ingelheim Investigational Site
  • Letland
      • Daugavpils, Letland
        • 1264.3.37105 Boehringer Ingelheim Investigational Site
      • Daugavpils, Letland
        • 1264.3.37112 Boehringer Ingelheim Investigational Site
      • Daugavpils, Letland
        • 1264.3.37113 Boehringer Ingelheim Investigational Site
      • Jelgava, Letland
        • 1264.3.37110 Boehringer Ingelheim Investigational Site
      • Liepaja, Letland
        • 1264.3.37101 Boehringer Ingelheim Investigational Site
      • Ogre, Letland
        • 1264.3.37106 Boehringer Ingelheim Investigational Site
      • Riga, Letland
        • 1264.3.37104 Boehringer Ingelheim Investigational Site
      • Riga, Letland
        • 1264.3.37108 Boehringer Ingelheim Investigational Site
      • Riga, Letland
        • 1264.3.37109 Boehringer Ingelheim Investigational Site
      • Riga, Letland
        • 1264.3.37111 Boehringer Ingelheim Investigational Site
      • Talsi, Letland
        • 1264.3.37107 Boehringer Ingelheim Investigational Site
      • Tukums, Letland
        • 1264.3.37102 Boehringer Ingelheim Investigational Site
      • Valmiera, Letland
        • 1264.3.37103 Boehringer Ingelheim Investigational Site
  • Spanje
      • Badía del Vallès - Barcelona, Spanje
        • 1264.3.34013 Boehringer Ingelheim Investigational Site
      • Barcelona, Spanje
        • 1264.3.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spanje
        • 1264.3.34008 Boehringer Ingelheim Investigational Site
      • Borges del Camp- Tarragona, Spanje
        • 1264.3.34005 Boehringer Ingelheim Investigational Site
      • Canet de Mar - Barcelona, Spanje
        • 1264.3.34006 Boehringer Ingelheim Investigational Site
      • Centelles - Barcelona, Spanje
        • 1264.3.34010 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spanje
        • 1264.3.34009 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat - Barcelona, Spanje
        • 1264.3.34004 Boehringer Ingelheim Investigational Site
      • Sant Adrià del Besós- Barcelona, Spanje
        • 1264.3.34002 Boehringer Ingelheim Investigational Site
      • Tarrega - Lleida, Spanje
        • 1264.3.34007 Boehringer Ingelheim Investigational Site
      • Valencia, Spanje
        • 1264.3.34012 Boehringer Ingelheim Investigational Site
      • Vic - Barcelona, Spanje
        • 1264.3.34011 Boehringer Ingelheim Investigational Site
  • Verenigd Koninkrijk
      • Annan, Verenigd Koninkrijk
        • 1264.3.44032 Boehringer Ingelheim Investigational Site
      • Ash Vale, Aldershot, Verenigd Koninkrijk
        • 1264.3.44028 Boehringer Ingelheim Investigational Site
      • Baillieston, Glasgow, Verenigd Koninkrijk
        • 1264.3.44029 Boehringer Ingelheim Investigational Site
      • Balham, Verenigd Koninkrijk
        • 1264.3.44008 Boehringer Ingelheim Investigational Site
      • Bradford on Avon, Verenigd Koninkrijk
        • 1264.3.44021 Boehringer Ingelheim Investigational Site
      • Burbage, Verenigd Koninkrijk
        • 1264.3.44019 Boehringer Ingelheim Investigational Site
      • Chesterfield, Verenigd Koninkrijk
        • 1264.3.44012 Boehringer Ingelheim Investigational Site
      • Chestfield, Whitstable, Verenigd Koninkrijk
        • 1264.3.44027 Boehringer Ingelheim Investigational Site
      • Chippenham, Verenigd Koninkrijk
        • 1264.3.44011 Boehringer Ingelheim Investigational Site
      • Johnstone, Verenigd Koninkrijk
        • 1264.3.44033 Boehringer Ingelheim Investigational Site
      • Midsomer Norton, Verenigd Koninkrijk
        • 1264.3.44007 Boehringer Ingelheim Investigational Site
      • Paisley, Verenigd Koninkrijk
        • 1264.3.44034 Boehringer Ingelheim Investigational Site
      • Warminster, Verenigd Koninkrijk
        • 1264.3.44031 Boehringer Ingelheim Investigational Site
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten
        • 1264.3.01026 Boehringer Ingelheim Investigational Site
      • Montgomery, Alabama, Verenigde Staten
        • 1264.3.01021 Boehringer Ingelheim Investigational Site
      • Muscle Shoals, Alabama, Verenigde Staten
        • 1264.3.01020 Boehringer Ingelheim Investigational Site
    • Arizona
      • Chandler, Arizona, Verenigde Staten
        • 1264.3.01062 Boehringer Ingelheim Investigational Site
      • Mesa, Arizona, Verenigde Staten
        • 1264.3.01064 Boehringer Ingelheim Investigational Site
    • California
      • Carmichael, California, Verenigde Staten
        • 1264.3.01049 Boehringer Ingelheim Investigational Site
      • Chino, California, Verenigde Staten
        • 1264.3.01078 Boehringer Ingelheim Investigational Site
      • Concord, California, Verenigde Staten
        • 1264.3.01031 Boehringer Ingelheim Investigational Site
      • Lakewood, California, Verenigde Staten
        • 1264.3.01037 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, Verenigde Staten
        • 1264.3.01065 Boehringer Ingelheim Investigational Site
      • Norwalk, California, Verenigde Staten
        • 1264.3.01006 Boehringer Ingelheim Investigational Site
      • Rancho Cucamonga, California, Verenigde Staten
        • 1264.3.01001 Boehringer Ingelheim Investigational Site
      • San Diego, California, Verenigde Staten
        • 1264.3.01059 Boehringer Ingelheim Investigational Site
      • Tarzana, California, Verenigde Staten
        • 1264.3.01023 Boehringer Ingelheim Investigational Site
      • Tustin, California, Verenigde Staten
        • 1264.3.01016 Boehringer Ingelheim Investigational Site
      • Valencia, California, Verenigde Staten
        • 1264.3.01058 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, Verenigde Staten
        • 1264.3.01083 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, Verenigde Staten
        • 1264.3.01027 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Norwalk, Connecticut, Verenigde Staten
        • 1264.3.01033 Boehringer Ingelheim Investigational Site
    • Florida
      • Boca Raton, Florida, Verenigde Staten
        • 1264.3.01035 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, Verenigde Staten
        • 1264.3.01015 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, Verenigde Staten
        • 1264.3.01082 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, Verenigde Staten
        • 1264.3.01036 Boehringer Ingelheim Investigational Site
      • Longwood, Florida, Verenigde Staten
        • 1264.3.01013 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Verenigde Staten
        • 1264.3.01038 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Verenigde Staten
        • 1264.3.01042 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Verenigde Staten
        • 1264.3.01079 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, Verenigde Staten
        • 1264.3.01019 Boehringer Ingelheim Investigational Site
      • St. Cloud, Florida, Verenigde Staten
        • 1264.3.01018 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Verenigde Staten
        • 1264.3.01009 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Verenigde Staten
        • 1264.3.01012 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, Verenigde Staten
        • 1264.3.01008 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, Verenigde Staten
        • 1264.3.01055 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, Verenigde Staten
        • 1264.3.01061 Boehringer Ingelheim Investigational Site
      • Blue Ridge, Georgia, Verenigde Staten
        • 1264.3.01074 Boehringer Ingelheim Investigational Site
      • Cartersville, Georgia, Verenigde Staten
        • 1264.3.01084 Boehringer Ingelheim Investigational Site
      • Perry, Georgia, Verenigde Staten
        • 1264.3.01060 Boehringer Ingelheim Investigational Site
      • Savannah, Georgia, Verenigde Staten
        • 1264.3.01050 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Verenigde Staten
        • 1264.3.01077 Boehringer Ingelheim Investigational Site
    • Indiana
      • Brownsburg, Indiana, Verenigde Staten
        • 1264.3.01052 Boehringer Ingelheim Investigational Site
      • Evansville, Indiana, Verenigde Staten
        • 1264.3.01075 Boehringer Ingelheim Investigational Site
      • Evansville, Indiana, Verenigde Staten
        • 1264.3.01076 Boehringer Ingelheim Investigational Site
      • Franklin, Indiana, Verenigde Staten
        • 1264.3.01073 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, Verenigde Staten
        • 1264.3.01002 Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, Verenigde Staten
        • 1264.3.01007 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten
        • 1264.3.01010 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten
        • 1264.3.01028 Boehringer Ingelheim Investigational Site
      • Sunset, Louisiana, Verenigde Staten
        • 1264.3.01029 Boehringer Ingelheim Investigational Site
    • Maryland
      • Hyattsville, Maryland, Verenigde Staten
        • 1264.3.01069 Boehringer Ingelheim Investigational Site
    • Michigan
      • Southfield, Michigan, Verenigde Staten
        • 1264.3.01066 Boehringer Ingelheim Investigational Site
    • Montana
      • Great Falls, Montana, Verenigde Staten
        • 1264.3.01057 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Burlington, North Carolina, Verenigde Staten
        • 1264.3.01045 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, Verenigde Staten
        • 1264.3.01044 Boehringer Ingelheim Investigational Site
    • Ohio
      • Zanesville, Ohio, Verenigde Staten
        • 1264.3.01022 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten
        • 1264.3.01032 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Fleetwood, Pennsylvania, Verenigde Staten
        • 1264.3.01051 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, Verenigde Staten
        • 1264.3.01025 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Columbia, South Carolina, Verenigde Staten
        • 1264.3.01081 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, Verenigde Staten
        • 1264.3.01003 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Verenigde Staten
        • 1264.3.01011 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, Verenigde Staten
        • 1264.3.01017 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Verenigde Staten
        • 1264.3.01067 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Verenigde Staten
        • 1264.3.01004 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Verenigde Staten
        • 1264.3.01039 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Verenigde Staten
        • 1264.3.01041 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Verenigde Staten
        • 1264.3.01047 Boehringer Ingelheim Investigational Site
      • Houston, Texas, Verenigde Staten
        • 1264.3.01070 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, Verenigde Staten
        • 1264.3.01040 Boehringer Ingelheim Investigational Site
      • Midland, Texas, Verenigde Staten
        • 1264.3.01048 Boehringer Ingelheim Investigational Site
      • New Braunfels, Texas, Verenigde Staten
        • 1264.3.01030 Boehringer Ingelheim Investigational Site
      • North Richland Hills, Texas, Verenigde Staten
        • 1264.3.01071 Boehringer Ingelheim Investigational Site
      • Plano, Texas, Verenigde Staten
        • 1264.3.01085 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, Verenigde Staten
        • 1264.3.01046 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, Verenigde Staten
        • 1264.3.01056 Boehringer Ingelheim Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
  3. Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
  4. BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
  5. Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
  2. Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
  3. Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
  4. Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
  5. Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
  6. Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)

  7. Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :

    • Diagnose of heart failure or history of heart failure
    • Haemodialysis patients, due to limited experience with pioglitazone
  8. Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
  9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
  11. Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
  12. Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures

  15. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.

    A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner

  16. Symptomatic gallbladder disease in the last six months
  17. Medical history of pancreatitis.
  18. Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
  19. Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
Geneesmiddel: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Actieve vergelijker: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
Geneesmiddel: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Actieve vergelijker: Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
Geneesmiddel: Pioglitazone 45 mg
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Actieve vergelijker: Linagliptin 5mg
Linagliptin 5mg Tablets once daily
Geneesmiddel: Linagliptin 5mg
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Experimenteel: Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Geneesmiddel: Linagliptin 5mg / Pioglitazone 15 mg FDC
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Experimenteel: Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Geneesmiddel: Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Experimenteel: Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Geneesmiddel: Linagliptin 5mg / Pioglitazone 45 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in HbA1c After 30 Weeks of Treatment.
Tijdsspanne: Baseline and 30 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Baseline and 30 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Tijdsspanne: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Tijdsspanne: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Tijdsspanne: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
HbA1c Change From Baseline by Visit Over Time
Tijdsspanne: Baseline, week 6, week 12, week 18, week 24, week 30

HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.

by visit interaction.
Baseline, week 6, week 12, week 18, week 24, week 30
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
Tijdsspanne: Baseline and 30 weeks
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Baseline and 30 weeks
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Tijdsspanne: Baseline, week 6, week 12, week 18, week 24, week 30
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Baseline, week 6, week 12, week 18, week 24, week 30
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
Tijdsspanne: Baseline and 30 weeks
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Baseline and 30 weeks
Time to First Use of Rescue Therapy
Tijdsspanne: 30 weeks
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
30 weeks
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Tijdsspanne: 30 weeks
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
30 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boehringer Ingelheim

Medewerkers

Eli Lilly and Company

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2010

Primaire voltooiing (Werkelijk)

1 februari 2013

Studie voltooiing (Werkelijk)

1 februari 2013

Studieregistratiedata

Eerst ingediend

16 augustus 2010

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2010

Eerst geplaatst (Schatting)

17 augustus 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

20 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

9 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1264.3
  • 2008-008127-15 (EudraCT-nummer: EudraCT)

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